BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240168 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11914
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CHECK PATIENT LINE ALARM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE PATIENT NOTICED THAT THERE WAS AIR IN THE PATIENT LINE. THERE WAS NO LOT NUMBER PROVIDED, THEREFORE NO BATCH REVIEW WAS PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HAVING A LOW DRAIN VOLUME ALARM WITH THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE LOW DRAIN VOLUME ALARM CLEARED AFTER TROUBLESHOOTING, BUT A CHECK PATIENT LINE ALARM OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP PERFORM MULTIPLE TROUBLESHOOTING STEPS AND THEN THE HP DISCOVERED AIR IN THE PATIENT LINE. THE HP WAS ADVISED TO END THERAPY THEN START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. GLOBAL PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE REPORTED EVENT. THE NURSE STATED SHE WAS AWARE OF THE ALARM AND WAS NOT SURE WHY THERE WAS AIR IN THE LINE. THE HP HAS BEEN ABLE TO COMPLETE THERAPY SINCE THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE